The demand for ophthalmic pharmaceuticals has rapidly increased, particularly in the case of eye drop formulations. The contemporary change in lifestyle, which is technology centric, has escalated the need for effective and safe sterile ophthalmic products. There is an increased need for protection in eye health, which includes the treatment of infections, inflammation, glaucoma, as well as dry eye syndrome and eye drops are widely used not only among adults but also in children.
Developing eye drops is a lot more complicated than making tablets or syrups. Controlled sterile conditions must be designed specifically for the manufacturing of eye drops, along with documented procedures for cleaning and personnel who are trained. Other legal requirements also impact the entire process from acquiring packaging materials to shipping the finished product. This is the reason why so many pharmaceutical marketers and startups today prefer eye drops third party manufacturing and private labeling.
Plena Remedies is an ophthalmic third-party manufacturer and marketer of Branded Generic Products based in Baddi, Himachal Pradesh. Now, what can they do for you? First, we need to understand the nuances and trends of the market to explain their opportunities and challenges as a third-party manufacturing partner for eye drops.
This business model pertains to pharmaceutical marketing companies contracting a licensed eye drops manufacturing company to make their ophthalmic solutions. The marketing company supplies the product specifications, a brand name and design instructions; the manufacturer does formulation, production, quality control and shipping.
This model seems to be more common in other areas of the pharmaceutical industry due to one or more of the following reasons:
• High Investment Requirements: The need for cleanrooms, sterile filling lines and other controlled environments for eye drops manufacturing incurs significant costs both to establish and maintain.
• Regulatory Constraints: The legal framework governing the ophthalmic medicine market is strict, accentuating the regulatory challenges for small and mid-sized pharma companies.
• Faster Market Entry: With third-party manufacturing, new companies can market products almost immediately because there is no need to wait for facility and machinery approvals.
• Focus on Branding and Distribution: Pharma companies are able to market their products, build their brand and expand their distribution network because manufacturing is outsourced.
What to Review Prior
to Selecting an Eye Drop Manufacturer
Companies need to assess the capability of their prospective manufacturers before entering an agreement with them.
1. Certifications
Never skip checking that the manufacturers have the following necessary certifications:
• WHO-GMP
• ISO 9001:2015
These certifications guarantee that the products are produced within good manufacturing practice and safe for the end-users.
2. Infrastructure
Eye drop manufacturing requires a very high level of cleanliness. Make sure these manufacturers have:
• Sterile zones and laminar airflow systems
• Cleanrooms with temperature and humidity control
• Automatic filling and sealing machines
• Water purification systems and in-house quality laboratories
3. Product Range
Consider manufacturers who can provide a complete range of ophthalmic products, which includes:
• Antibiotic eye drops
• Anti-inflammation steroid drops
• Lubricating eye drops for dry eyes
• Anti-allergy and antihistamine eye drops
• Anti-glaucoma eye drops
4. Packaging and Customization
Select a manufacturer who can provide all necessary selling tools like:
• Packaging of different sizes 5ml, 10ml, 15ml
• Bottles that are tamper-proof and sterile
• Printing support for branding and labels
• Batch and expiry date printing
5. Transparency and Timelines
Good business partners should be consistent with unit pricing and their operations. They ought to follow the delivery timelines while giving the clients adequate feedback throughout the process.
Benefits of Selecting Plena Remedies for eye drops third party manufacturing
We specializes in partnering with businesses who are looking for eye drops third party manufacturing, making them a trusted collaborator to many pharmaceutical companies. It offers a decade of experience along with a modern manufacturing unit located in Baddi, blending affordability and professionalism.
Certified Manufacturing excellence
We are the holder of a WHO-GMP and ISO 9001:2015 certified facility for sterile manufacturing. The Plant features:
• Advanced areas for sterilization with HVAC units
• Eye drop filling and sealing lines
• Clean rooms free of dust
• In-house microbiology and analytical labs
Patients all over the world have access to their products because each batch is tested against stringent quality control standards to global benchmarks.
One Stop Shop
Plena Remedies serves the market with a wider ophthalmic range under one roof which includes;
• Antibiotic Drops
• Anti-inflammatory Drops
• Dry Eye Solutions
• Anti-Allergic Drops
• Anti-Glaucoma Drops
Every product is produced from high-purity APIs, accompanied with documents for every batch produced and validated against standards.
End-to-End Customization and Branding
Plena Remedies customizes branding as per branding requirements of clients which includes support in:
• Designing the product label
• Printing the carton and other packaging materials
• Designing bottles of particular sizes and colors
• Assisting with batch coding, product registration and regulatory documentation
We will help you launch a new brand or help in scaling existing brands, as our design and packaging team makes sure that the product will be eye-catching in the ophthalmic market.
Client-Centric Support
We have good client management which is the top priority where communication is maintained throughout the manufacturing affair. Their separate unit for third parties looks after:
• Queries pertaining to the products and estimation of costs
• Regulatory documentation business support
• Producing documents within agreed timeframes for scheduled works
• Assistance after the manufacturing processes are completed
The company provides all these services while maintaining their good reputation with clients and is further known for the unchanging pricing, reasonable minimum order quantities and low scalable ranges of production.
Documentation and Compliance
Every batch is sent with comprehensive documentation that includes:
• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Stability Data (provided only if requested)
• Documentation of compositional and technical details of the product
Guidelines for labeling the product per Indian regulations on label compliance for marking materials intended for identification of the product.
Collaborate with Plena Remedies
As one of the leading companies in India, Plena Remedies has a good eye drops third party manufacturing service that will help you establish or expand your ophthalmic product line. They offer a strong and fast growing infrastructure which guarantees that they have all the processes and people necessary to get your products into the market within the shortest possible time.
You can be sure that they will work with your business as best as possible because they are flexible, use modern technology and offer customization. Because of this, they are best suited for any size pharma company.
1. What does third party manufacturing mean in the case of eye drops?
This is when a pharmaceutical company delegates the production of eye drops to a licensed contract manufacturer.
2. Who is eligible for third party manufacturing for eye drops?
Pharmaceutical Companies, new entrants, or marketers intend to brand and promote ophthalmic products under their own label.
3. What is the minimum documentation required to start the manufacturing process?
To commence, typically a drug license, GST certificate and details of the company are a prerequisite.
4. What specific kinds of eye drops can be produced?
Eye-Antiobiotic, Eye anti inflammatory drops, Eye lubricants, Eye anti allergy drops, Eye anti glaucoma drops are some of the most common.
5. Does Plena Remedies allow for tailored branding for packaging?
We make tailored branding for packaging available including labels, packaging and bottles according to the specification of their clients.